ACE-CF: Detecting lung exacerbations in adults with CF using artificial intelligence

Full title

A study to look at using artificial intelligence (AI) to predict lung exacerbations in CF (ACE-CF)

Study details

This study will evaluate a new AI feature on the Breathe RM smartphone app called Breathe RM Signal. The feature aims to predict flare-ups of lung symptoms (known as exacerbations) and reduce unnecessary routine hospital visits for people with CF.

Breathe RM smartphone app has been co-designed with people with CF. Breathe RM is currently being used in Project Breathe, a study which empowers people with CF to take control of their own health. The app allows participants to monitor themselves at home with Bluetooth connected devices including a spirometer, activity monitor, and weighing scales. This data can then be shared via a portal with their clinical care team. In preliminary studies we have shown that home monitoring empowers people with CF and can safely reduce routine outpatient hospital attendance.

Breathe RM Signal is a feature of the Breathe RM app that works as a decision aid for people with CF. It uses AI and data from the app to assess if people with CF are stable or at risk of having an exacerbation that needs treatment. Participants are then able to see an easy-to-understand colour coded risk score on the Breathe RM app with instructions of what they need to do.

This study will evaluate the effectiveness of people with CF viewing their home monitoring data alone (using the Breathe RM app) compared to viewing it alongside the AI app feature (Breathe RM Signal).

What will participants be asked to do?

All participants will be given an activity monitor, weighing scales, oxygen saturation monitor and spirometer (to measure lung function) to use at home. Participants will be asked to use these home monitoring devices daily if possible, or a minimum of 5 days per week. These devices connect to the app via Bluetooth. The results from these devices can then be seen by the participant and by their clinical team (if the participant agrees to this).

Participants will be randomly allocated to be in one of two groups. There will be 200 participants in each group.

• Group 1 will see their data from home monitoring only (using Breathe RM).
• Group 2 will see their data from home monitoring (using Breathe RM) plus the Breathe RM Signal feature. 

Participants in both groups will be asked to complete a user acceptability questionnaire every 3 months. They’ll also be asked to complete a health-related quality of life questionnaire at the start of the study and then every 3 months. Each questionnaire can be completed on paper or electronically and takes around 15 minutes to complete.

Participants will be asked if they would like to participate in virtual (or one-to-one) discussions to give feedback regarding how they found using Breathe RM and/or Breathe RM Signal.

People with CF have been involved in every stage of the design process and will continue to be involved throughout the study and sharing of results.

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